- Patients must have measurable disease or evaluable disease for the escalation phase; for the 6 additional patients enrolled at MTD for further evaluation of PK and PD endpoints (Expansion Cohort A). For the 6-patient BRCA-mutation expansion cohort, patients must have measurable disease; however, tumor biopsies are optional. For Expansion Cohort B, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or H & N lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration. Criteria for the submission of tissue are: